NAPM Plans To Reiterate Generic Equivalency To MD Groups: AMA, AAP
Executive Summary
The National Association of Pharmaceutical Manufacturers is seeking meetings with professional medical societies to reiterate the message that generic drugs are therapeutically equivalent to reference brands.
You may also be interested in...
Pediatric Exclusivity Will Not Irreparably Harm Generic Firms, Court Says
Exclusivity extensions under FDAMA's pediatric provisions will not cause "irreparable harm" to generic drug manufacturers, D.C. Federal Court Judge James Robertson maintained in an April 20 denial of a generics industry motion for preliminary injunction.
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials